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Anatomical and functional outcomes of uterus preservation and pelvic organ prolapse repair with vaginal trocar-less mesh kit (Endofast): A retrospective study of 239 patients.
OBJECTIVE: The aim of the study was to assess safety and long term efficacy as well as short and long term complications of vaginal prolapse mesh repair using single incision trocar-less system while preserving the uterus.
STUDY DESIGN: A single-center, retrospective cohort study including all patients who underwent vaginal prolapse mesh repaier surgery with EndoFast Reliant™ kit between October 2010 and January 2015. Outcomes included anatomical changes (POP-Q), overactive bladder symptoms (OAB) stress urinary incontinence (SUI), sexual function and constipation as well as the rate of surgical failure, immediate and long-term complications.
RESULTS: 239 women, with an average follow-up period of 1.7 years (range: 6 weeks to 7 years), were included. Uterus was preserved in 87 % of patients (184 out of 211 patients with intact uterus) and concurrent surgery for SUI was performed in 46 %. POP-Q significantly improved as well as OAB and SUI symptoms and remained without significant change during follow-up period. In 11 patients (4.6 %) a new/recurrent prolapse was observed during the follow up period. Immediate complications occurred in 4 patients. One case of bladder perforation, one case of mesh contamination, 2 cases of urinary retention, one of them permanent. Late complications included mesh erosion, de novo dyspareunia, cervical elongation and de-novo SUI, and were observed in 38 cases (16 %). Surgical intervention was required in 20 (8.4 %) cases; 10 cases of de-novo SUI, 2 cases of partial mesh removal because of dyspareunia, 1 case of mid urethral sling removal because of erosion and 7 cases of cervical amputation.
CONCLUSIONS: Repair of prolapse with vaginal trocar-less mesh kit while preserving the uterus for the majoroty of women, is a relatively safe and effective surgery,with a low incidence of complications and re-operation rate which was mainly for de novo SUI or elongation of cervix. Randomiesed prospective long term studies are neaded to establish the results.
STUDY DESIGN: A single-center, retrospective cohort study including all patients who underwent vaginal prolapse mesh repaier surgery with EndoFast Reliant™ kit between October 2010 and January 2015. Outcomes included anatomical changes (POP-Q), overactive bladder symptoms (OAB) stress urinary incontinence (SUI), sexual function and constipation as well as the rate of surgical failure, immediate and long-term complications.
RESULTS: 239 women, with an average follow-up period of 1.7 years (range: 6 weeks to 7 years), were included. Uterus was preserved in 87 % of patients (184 out of 211 patients with intact uterus) and concurrent surgery for SUI was performed in 46 %. POP-Q significantly improved as well as OAB and SUI symptoms and remained without significant change during follow-up period. In 11 patients (4.6 %) a new/recurrent prolapse was observed during the follow up period. Immediate complications occurred in 4 patients. One case of bladder perforation, one case of mesh contamination, 2 cases of urinary retention, one of them permanent. Late complications included mesh erosion, de novo dyspareunia, cervical elongation and de-novo SUI, and were observed in 38 cases (16 %). Surgical intervention was required in 20 (8.4 %) cases; 10 cases of de-novo SUI, 2 cases of partial mesh removal because of dyspareunia, 1 case of mid urethral sling removal because of erosion and 7 cases of cervical amputation.
CONCLUSIONS: Repair of prolapse with vaginal trocar-less mesh kit while preserving the uterus for the majoroty of women, is a relatively safe and effective surgery,with a low incidence of complications and re-operation rate which was mainly for de novo SUI or elongation of cervix. Randomiesed prospective long term studies are neaded to establish the results.
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